A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Start Date
11/24/2025
Completion Date
11/1/2027
Summary
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Brenipatide
Placebo
Conditions
Locations
ATP Clinical Research
Orange, California 92866
United States
Yale University School of Medicine
New Haven, Connecticut 06519
United States
AGA Clinical Trials
Hialeah, Florida 33012
United States
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida 32751
United States
K2 Medical Research - Maitland
Maitland, Florida 32751
United States
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
United States
CLA Research
Naples, Florida 34116
United States
Charter Research - Orlando
Orlando, Florida 32803
United States
Encore Medical Research - Weston
Weston, Florida 33331
United States
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United States
Covenant Medical Center
Waterloo, Iowa 50702
United States
CBH Health
Gaithersburg, Maryland 20877
United States
Elixia MA
Springfield, Massachusetts 01103
United States
Adams Clinical Watertown
Watertown, Massachusetts 02472
United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United States
Revival Research Institute, LLC
McKinney, Texas 75071
United States
Pillar Clinical Research - Richardson
Richardson, Texas 75080
United States
Alpine Research Organization
Clinton, Utah 84015
United States
Re:Cognition Health
Fairfax, Virginia 22031
United States
Northwest Clinical Research Center
Bellevue, Washington 98007
United States
Hospital Italiano de Buenos Aires
ABB, C1199ABB
Argentina
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires, 1058
Argentina
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires, 1405
Argentina
Stat Research S.A.
Buenos Aires, C1023AAB
Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
Argentina
Instituto Médico DAMIC
Córdoba, X5003DCE
Argentina
Instituto Kremer
Córdoba, X5004AOA
Argentina
Centro Médico Luquez
Córdoba, X5006CBI
Argentina
Global Psy Asociación Civil
La Plata, 1904
Argentina
Fundacion Scherbovsky
Mendoza, 5500
Argentina
INECO Neurociencias Oroño
Rosario, 2000
Argentina
Clinica El Jardin
Santiago del Estero, 4200
Argentina
Chronos Pesquisa Clínica
Brasília, 72145-450
Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
Brazil
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150
Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030
Brazil
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, 04020-060
Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, 13271-130
Brazil
The Second People's Hospital of Hunan Province
Changsha, 410007
China
The Seventh People's Hospital of Hangzhou
Hangzhou, 310000
China
3rd People's Hospital of Huzhou
Huzhou, 313000
China
Shangdong Mental Health Center
Jinan, 250012
China
Shanghai Mental Health Center
Shanghai, 200030
China
Shanghai Tongji Hospital
Shanghai, 200065
China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
China
Tianjin Anding Hospital
Tianjin, 300022
China
Xiamen Xianyue Hospital
Xiamen, 361012
China
Zhumadian Psychiatric Hospital
Zhumadian, 463000
China
Galaxy Superspeciality Hospital
Aurangabad, 431001
India
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, 590019
India
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, 462024
India
Society for Psychiatric Update and Research
Chhatrapati Sambhajinagar, 431005
India
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, 248008
India
Dharwad Institute Of Mental Health And Neurosciences
Dharwad, 580008
India
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010
India
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow, 226020
India
Mysore Medical College
Mysore, 570001
India
Assured Care Plus Hospital
Nashik, 422101
India
Lifepoint Multispeciality Hospital
Pune, 411057
India
Sowmanasya Hospital and Institute of Psychiatry
Tiruchirappalli, 620002
India
Deva Institute Of Healthcare Research
Varanasi, 221005
India
Uematsu Mental Clinic
Chikugo, 833-0041
Japan
Jimbocho Mental Clinic
Chiyoda City, 101-0051
Japan
Horikoshi Mental Somatic Clinic
Fukushima, 960-8053
Japan
Saitama Medical University Hospital
Iruma, 350-0495
Japan
Rainbow and Sea Hospital
Karatsu, 847-0031
Japan
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047
Japan
Suizenji Life Clinic
Kumamoto, 862-0956
Japan
Kure Medical Center
Kure, 737-0023
Japan
Hirota Clinic
Kurume, 830-0033
Japan
Yutaka Clinic
Sagamihara, 252-0303
Japan
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
Japan
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, 162-0843
Japan
Ikebukuro Olive Mental Clinic
Toshima City, 170-0013
Japan
Yamagata Sakuracho Hospital
Yamagata, 990-0045
Japan
Miki Mental Clinic
Yokohama, 220-0023
Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31203
Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
Mexico
B&B Investigaciones Medicas S.C.
Mazatlán, 82103
Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, 04100
Mexico
Ketamine Clinic México
Mexico City, 04100
Mexico
Medical Care and Research SA de CV
Mérida, 97070
Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260
Mexico
SCB Research Center
Bayamón, 00961
Puerto Rico